Phase II Randomized Controlled Study Aiming to Evaluate the Interest of Qutenza in Patients With ORL Cancer in Remission and With Sequellae Neuropathic Pain.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Oncopole Claudius Regaud

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

28 Apr 2021 → 28 Apr 2025

Decision date (initial)

2024-08-13

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Direction Générale de l'Offre de Soins (DGOS)

External identifiers

EU CT number

2024-515510-41-00

EudraCT number

2020-003965-21

ClinicalTrials.gov

NCT04704453

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

This study aims to compare the analgesic activity of capsaicin patch 8% applications at 3 months interval each on the cervico-facial area versus a reference neuropathic treatment with amitriptyline in patients with ORL cancer in remission and with neuropathic pain.

Secondary objectives 4

1. A sensitivity study to assess the influence of managing pain other than neuropathic pain
2. Compare safety and tolerance between treatment arms
3. To compare the evolution of neuropathic pain between treatment arms
4. Compare quality of life between treatment arms

Conditions and MedDRA coding

Head and neck cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Age ≥ 18 years
2. ORL cancer in remission: absence of clinical or radiological signs of progression at least 3 months after specific treatments.
3. Pain of the cervico-facial sphere persisting for more than 3 months after surgical and/or radiotherapy treatment.
4. Peripheral neuropathic character of pain objectified to a score ≥ 4/10 on the DN4 questionnaire.
5. Pain whose average intensity over the last 24 hours is assessed on the numerical scale as ≥ 2/10.
6. Postmenopausal patient or patient who agrees to use effective contraception for the duration of treatment and for a minimum of 15 days after the end of the treatment period. Non-menopausal patients must have a negative pregnancy test prior to inclusion in the study.
7. Patient affiliated to a Social Health Insurance in France.
8. Patient who signed informed consent prior to inclusion in the study and prior to any specific study procedures.

Exclusion criteria 16

1. ORL cancer in progression.
2. Other concomitant neoplasia (progressive or not).
3. Central etiology of pain.
4. Pain whose average intensity over the last 24 hours is assessed on the numerical scale as < 2/10.
5. Allergy to any of the components of the capsaicin patch.
6. Capsaicin patch not applicable to the area to be treated despite the precautions described in the protocol because of its proximity to mucous membranes or eyelids.
7. Contraindication to amitriptyline treatment.
8. Patient with an unhealed skin lesion on the area to be treated.
9. Previous treatment with capsaicin or amitriptyline.
10. Topical treatment of the painful area used for more than 21 days before inclusion.
11. Ongoing opioid treatment > 80mg/day oral morphine equivalent.
12. Uncontrolled high blood pressure or cardiovascular history (infarction, stroke, pulmonary embolism) less than 3 months ago.
13. Patient included in another interventional therapeutic trial.
14. Pregnant or breastfeeding patient.
15. Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of the study protocol.
16. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The Primary Outcome Measure is the rate of patients with a decrease in average pain over the last 24 hours by 2 points at 9 months compared to inclusion.

Secondary endpoints 4

1. For the sensitivity analysis, the endpoint will be defined as the rate of patients with a decrease in average pain over the last 24 hours by 2 points at 9 months compared to inclusion. Pain will be assessed using a numerical scale. Patients for whom pain management would be modified from the protocol will be considered failures. Patients with missing data for pain progression will be considered failures.
2. Neuropathic pain will be assessed using the Neuropathic Pain Symptom Inventory (NPSI) self-questionnaire developed and validated in French (Bouhassira, Pain 2014).
3. Adverse drug reactions (capsaicin and amitriptyline) will be assessed using the NCI-CTC AE V5.
4. Quality of life will be assessed using the EORTC QLQ-C30 questionnaire.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Oncopole Claudius Regaud

Sponsor organisation

Oncopole Claudius Regaud

Address

1 Avenue Irene Joliot Curie

City

Toulouse

Postcode

31100

Country

France

Scientific contact point

Organisation

Oncopole Claudius Regaud

Contact name

Docteur Antoine BODEN

Public contact point

Organisation

Oncopole Claudius Regaud

Contact name

Muriel MOUNIER

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Documents 1 file

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications